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Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This single-center, prospective, randomized, controlled, assessor-blinded study will evaluate the efficacy and safety of Piclosept® ophthalmic solution as an adjunct to standardized lacrimal sac massage in children aged 1 to 12 months with neonatal dacryocystitis. Participants will be randomized in a 1:1:1 ratio to standardized lacrimal sac massage alone, massage plus preservative-free levofloxacin, or massage plus Piclosept®. The primary outcome is clinical success on Day 14, defined as complete absence of purulent-mucoid discharge and reflux of purulent-mucoid material.
Trial Details
NCT Number NCT07875517
Lead Sponsor Kazakh Eye Research Institute
Conditions
(from sponsor)
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov